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A Clinical Trial Comparing Surfactant Administration Through Supraglottic Airway or Thin Catheter for Preterm Infants

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better. Surfactant can be given using a thin tube (Less Invasive Surfactant Administration, called the LISA method) or through a small airway device placed in the baby's throat above the vocal cords (Surfactant Administration through Laryngeal or Supraglottic Airway, called the SALSA method). The goal is to see which method is safer and more effective for preterm infants who are born at or after 29 weeks of pregnancy and have trouble breathing. What is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer heart rate and breathing-related problems than those who receive it using the LISA method. What are the aims? Aim 1: Are babies in the SALSA group less likely to have low heart rate or low oxygen levels during the procedure compared to babies in the LISA group? Aim 2: Do fewer babies in the SALSA group need to be put on a breathing machine within the first 72 hours of life? Aim 3: Does the SALSA method help reduce the overall time babies need breathing support and lower the cost of their care in the NICU?

Eligibility
Participation Requirements
Sex: All
Maximum Age: 3 days
Healthy Volunteers: f
View:

• All preterm infants born at or greater than 29 weeks' gestational age (29-36 weeks' GA)

• Infants with birthweight greater than or equal to 750 grams and admitted to the NICU on CPAP for respiratory support requiring FiO2 25% and qualify for LISA procedure

Locations
United States
Texas
Parkland Health and Hospital Systems
RECRUITING
Dallas
Contact Information
Primary
Melody Chiu, M.D.
melody.chiu@utsouthwestern.edu
214-648-3903
Backup
Kathryn Mazioniene, R.N.
kathryn.mazioniene@utsouthwestern.edu
Time Frame
Start Date: 2026-08-05
Estimated Completion Date: 2030-08
Participants
Target number of participants: 40
Treatments
Experimental: Surfactant Administration through Laryngeal or Supraglottic Airway
Active_comparator: Surfactant Administration through Thin Catheter
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov